BoMRA BOMRABOMRA/ER/MED/P04/G02
BOMRA/ER/MED/P04/G02 is the official BoMRA identifier for “Guidance on Clinical Evaluation of Medical Devices including IVDs”. BOMRA/ER/MED/P04/G02 is the official identifier BoMRA uses for this instrument.
- Instrument
- BOMRA
- Full name
- BOMRA/ER/MED/P04/G02
- Category
- Clinical Trials
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- —
- Effective
- 2022-04-01
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guidance on Clinical Evaluation of Medical Devices including IVDs
Issue 1.0, effective 1 April 2022. How a manufacturer demonstrates clinical evidence for a Botswana registration: the clinical evaluation plan and report, the literature route, equivalence, the clinical-investigation route where the other two do not suffice, and the IVD-specific performance evaluation. The document's own cover calls it a "Guideline for Clinical Evaluation of Medical Devices including IVDs" while the registry title used here reads "Guidance on Clinical Evaluation"; the Document No BOMRA/ER/MED/P04/G02 is the same either way, and the registry title is the one the batch declaration carries.
BOMRA/ER/MED/P04/G02 is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.